National Coverage Analysis (NCA) Tracking Sheet

Transcatheter Tricuspid Valve Replacement (TTVR)



Tricuspid regurgitation (TR) occurs when the valve between the right atrium and right ventricle does not function properly and blood flows from the right ventricle back into the right atrium. TR can lead to symptoms of leg swelling, fluid accumulation in the abdomen, an enlarged spleen and liver, and heart failure. Transcatheter Tricuspid Valve Replacement (TTVR) is a new technology for use in treating TR. A bioprosthetic valve is inserted using a catheter and implanted inside the native tricuspid valve.

CMS received a complete, formal request to provide coverage for the EVOQUE tricuspid valve replacement system (EVOQUE system).

This NCA will focus on the clinical indications for use of TTVR among Medicare beneficiaries. This NCA will analyze clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from the device and whether specific treatment conditions are necessary to achieve the outcomes demonstrated in clinical studies. Other outcomes of interest may include decreased mortality, decreased frequency of exacerbations requiring emergency room or hospital admission, improved function, and quality of life. The scope of this NCA is limited to TTVR for TR.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of TTVR. We are also interested in health disparities and equity aspects that should be considered in the review.

National Coverage Determinations

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Edwards Lifesciences View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
06/20/2024 - 07/20/2024
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
David Dolan
Lead Medical Officers
Laura Findeiss, MD, MHA

Medicare Benefit Category Determination Date

Actions Taken

June 20, 2024

CMS initiates this national coverage analysis for Transcatheter Tricuspid Valve Replacement (TTVR). The 30-day public comment period begins with this posting date and ends after 30 calendar days. CMS considers all public comments and is particularly interested in clinical studies and other scientific information relevant to the topic under review. We are also interested in health disparities and equity aspects that should be considered in the review.

Instructions on submitting comments can be found at: To submit a comment, please use the blue "Comment" button at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.